FDA to Set High Bar for Emergency COVID-19 Vaccine Approvals - COVID-19 Clinical Trial
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FDA to Set High Bar for Emergency COVID-19 Vaccine Approvals

The FDA is set to take a tough line on the evidence required to support emergency use authorization (EUA) of COVID-19 vaccines, according to The Washington Post. The reported requirements suggest a company is unlikely to have the data needed to support an EUA before the election in six weeks.  President Donald Trump has repeatedly predicted a vaccine will be ready for the election in the first week of November. The potential political benefits of hitting that target, coupled to events such as the convalescent plasma EUA press conference, have raised concerns that the FDA will come under pressure to authorize a vaccine before the election.

No company is likely to satisfy the requirements for full approval early enough to have a submission reviewed by early November, leaving an EUA as the most probable route to a preelection vaccine. The FDA dedicated just a few paragraphs of its existing COVID-19 vaccine guidance to EUAs, stating little more than that emergency authorization may be appropriate “once studies have demonstrated the safety and effectiveness of the vaccine.”


U.S. Health Secretary Says AstraZeneca Trial in United States Remains on Hold

U.S. Health and Human Services Secretary Alex Azar said on Wednesday that the U.S. trial of AstraZeneca PLC’s COVID-19 vaccine remains on hold while the U.S. Food and Drug Administration investigates a patient illness that shut down the global trial.

Azar said that the FDA’s investigation, which has continued even after the trial has resumed outside of the United States, shows that the agency takes safety of the vaccine seriously.

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